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NCT03234972CompletedPhase 3

A Study to Compare Daratumumab, Bortezomib, and Dexamethasone (DVd) vs Bortezomib and Dexamethasone (Vd) in Chinese Participants With Relapsed or Refractory Multiple Myeloma

A Randomized, Multicenter, Open-label, Phase 3 Study to Compare Daratumumab, Bortezomib, and Dexamethasone (DVd) vs Bortezomib and Dexamethasone (Vd) in Chinese Subjects With Relapsed or Refractory Multiple Myeloma

Source: ClinicalTrials.gov · Last updated 29 May 2024

Brief summary (registry, in English)

The primary purpose of this study is to compare the efficacy of daratumumab when combined with Velcade (bortezomib) and dexamethasone (DVd) to that of Velcade and dexamethasone (Vd), in terms of progression free survival (PFS) in Chinese participants with relapsed or refractory multiple myeloma (MM).

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
213 (actual)
First submitted
27 Jul 2017
Start date
30 Nov 2017
Primary completion date
7 Oct 2019
Lead sponsor
Janssen Research & Development, LLC
NCT number
NCT03234972

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 213
  • From 30 Nov 2017 to the primary completion date, 7 Oct 2019
  • 27 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Received daratumumab or other anti-CD38 therapies
  • Refractory to Velcade, or another proteasome inhibitor (PI), like ixazomib and carfilzomib (ie, participant had progression of disease while receiving Velcade therapy or within 60 days of ending Velcade therapy, or another PI, like ixazomib and carfilzomib, etc)
  • Planning to undergo a stem cell transplant prior to progression of disease on this study, that is ie, these participants should not be enrolled in order to reduce disease burden prior to transplant

Other illness

  • History of malignancy (other than MM) within 3 years before the date of randomization

Other

  • Intolerant to Velcade (that is \[ie\], discontinued due to any adverse event while on Velcade treatment)

Who the study is looking for

  • Documented multiple myeloma (MM) as defined by the criteria: monoclonal plasma cells in the bone marrow greater than or equal to (\>=) 10 percent (%) at some point in the participant's disease course or presence of a biopsy-proven plasmacytoma
  • Received at least 1 prior line of therapy for MM
  • Documented evidence of progressive disease (PD) based on investigator's determination of response as defined by the International Myeloma Working Group (IMWG) criteria on or after their last regimen
  • Achieved a response (partial response \[PR\] or better based on investigator's determination of response by the IMWG criteria) to at least 1 prior regimen
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (27)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Peking University First Hospital
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BeijingChinaUnknown status
Peking Union Medical College Hospital
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BeijingChinaUnknown status
Peking University Third Hospital
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BeijingChinaUnknown status
Peking University People's Hospital
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BeijingChinaUnknown status
The First Hospital of Jilin University
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ChangchunChinaUnknown status
West China Hospital Si Chuan University
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ChengduChinaUnknown status
Xinqiao Hospital of the Third Military Medical University
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ChongqingChinaUnknown status
Fujian Meidical University Union Hospital
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FuzhouChinaUnknown status
Nanfang Hospital
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GuangzhouChinaUnknown status
The First Affiliated Hospital, Sun Yat-sen University
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GuangzhouChinaUnknown status
Guangdong Provincial People's Hospital
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GuangzhouChinaUnknown status
First Affiliated Hospital Medical School of Zhejiang University
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HangzhouChinaUnknown status
First Affiliated Hospital of Zhejiang University
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HangzhouChinaUnknown status
Jiangsu Province Hospital
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NanjingChinaUnknown status
Nanjing Drum Tower hospital
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NanjingChinaUnknown status
Zhongda Hospital Southeast University
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NanjingChinaUnknown status
Shanghai Changzheng Hospital
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ShanghaiChinaUnknown status
Ruijin Hospital Shanghai Jiao Tong University
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ShanghaiChinaUnknown status
First Affiliated Hospital SooChow University
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SuzhouChinaUnknown status
Tianjin Cancer Hospital
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TianjinChinaUnknown status
Institute of Hematology and Blood Diseases Hospital
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TianjinChinaUnknown status
Tianjin Medical University General Hospital
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TianjinChinaUnknown status
Tongji Hospital Tongji Medical College of Hust
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WuhanChinaUnknown status
Tangdu Hospital
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Xi'anChinaUnknown status
Henan Cancer Hospital
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ZhengzhouChinaUnknown status
National Taiwan University Hospital
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TaipeiTaiwanUnknown status
Tri-Service General Hospital
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TaipeiTaiwanUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.